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U.S. FDA Medical Device Radiographic Test-Pattern Requirements


FDA Medical Device Definition: A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

Registrar Corp assists Radiographic Test-Pattern companies with:

  • FDA Radiographic Test-Pattern Establishment Registration
  • FDA Radiographic Test-Pattern Listing
  • FDA Radiographic Test-Pattern Label Requirements and Exceptions
  • FDA Radiographic Test-Pattern Import Information
  • FDA Radiographic Test-Pattern Detentions (Radiographic Test-Pattern Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Radiographic Test-Pattern Manufacturers (Radiographic Test-Pattern Suppliers)
       - Radiographic Test-Pattern Distributors
       - Radiographic Test-Pattern Processors
       - Radiographic Test-Pattern Repackers
       - Radiographic Test-Pattern Relabelers
       - Radiographic Test-Pattern Exporters
       - Radiographic Test-Pattern Importers
For more information about Radiographic Test-Pattern Medical Devices, simply click below:






 
U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.


Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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